Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00620100 |
To determine the Objective Response Rate of 4 cycles of docetaxel + anthracycline (epirubicin or doxorubicine) followed by 4 cycles of docetaxel single agent. To determine the Time to Tumor Progression (TTP), the Response Duration, the Overall Survival. To confirm the safety profile
Condition | Intervention | Phase |
---|---|---|
Breast Neoplasms |
Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Single Group Assignment |
Official Title: | A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel (Taxotere®) + Anthracycline (Epirubicin or Doxorubicin) x 4 Cycles Followed by Docetaxel (T) Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed > or = 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®-Based Chemotherapy |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function defined by :
Exclusion Criteria:
Other serious illness or medical conditions, including:
Past or current history of neoplasm other than breast carcinoma, except:
Study ID Numbers: | XRP6976A/2504 |
Study First Received: | February 11, 2008 |
Last Updated: | February 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00620100 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Docetaxel Skin Diseases Breast Neoplasms |
Epirubicin Doxorubicin Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |